MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-01 for 112-7178 manufactured by Bovie Medical Corporation.
[115774243]
Reported complaint alleged that the activation of the high temperature cautery gets stuck during surgery during surgery. No patient injury associated with the reported complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007593903-2018-00043 |
| MDR Report Key | 7740787 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-07-05 |
| Device Manufacturer Date | 2018-02-06 |
| Date Added to Maude | 2018-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS DANNELLE LAO |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal | 337604004 |
| Manufacturer Phone | 7278038554 |
| Manufacturer G1 | BOVIE MEDICAL CORPORATION |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 337604004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 112-7178 |
| Generic Name | HIGH TEMPERATURE |
| Product Code | GEI |
| Date Received | 2018-08-01 |
| Model Number | 112-7178 |
| Catalog Number | 112-7178 |
| Lot Number | 0218F |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BOVIE MEDICAL CORPORATION |
| Manufacturer Address | 5115 ULMERTON ROAD CLEARWATER FL 337604004 US 337604004 |
| Brand Name | 112-7178 |
| Generic Name | HIGH TEMPERATURE |
| Product Code | HQP |
| Date Received | 2018-08-01 |
| Model Number | 112-7178 |
| Catalog Number | 112-7178 |
| Lot Number | 0218F |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOVIE MEDICAL CORPORATION |
| Manufacturer Address | 5115 ULMERTON ROAD CLEARWATER FL 337604004 US 337604004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-01 |